This systematic review by Carragee et al. compares the safety conclusions of 13 original industry-sponsored rhBMP-2 spinal fusion trials (780 patients) against FDA data summaries, follow-up publications, and administrative databases — asking whether the published literature accurately reflected the true complication profile of rhBMP-2.
When evaluating rhBMP-2 for routine single-level lumbar fusion, recognize that the original safety literature was systematically biased: true adverse event rates are 10–50x higher than originally reported, the NNT to avoid one revision fusion is ~100, and specific high-risk applications (PLIF/TLIF, anterior cervical, high-dose formulations) carry substantial complication burdens — including retrograde ejaculation, ectopic bone, osteolysis, and a possible malignancy signal.
That must be disclosed during informed consent.
This systematic review by Carragee et al. compares the safety conclusions of 13 original industry-sponsored rhBMP-2 spinal fusion trials (780 patients) against FDA data summaries, follow-up publications, and administrative databases — asking whether the published literature accurately reflected the true complication profile of rhBMP-2.
When evaluating rhBMP-2 for routine single-level lumbar fusion, recognize that the original safety literature was systematically biased: true adverse event rates are 10–50x higher than originally reported, the NNT to avoid one revision fusion is ~100, and specific high-risk applications (PLIF/TLIF, anterior cervical, high-dose formulations) carry substantial complication burdens — including retrograde ejaculation, ectopic bone, osteolysis, and a possible malignancy signal.
That must be disclosed during informed consent.